Critical IllnessNCT07251764
The Blood-Interstitial Glucose Gap
An observational study of Critical Illness and Metabolism Disorders, run by Chinese Medical Association at 1 site in China.
Trial summary
Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Metabolism Disorders
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2023to 1 Oct 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patient
Who may be able to join
- Age≥ 18 years and < 80 years
- ICU stay ≤48 hours
- Expected ICU stay > 24 hours
- APACHE II score≥ 8
Who cannot join
- local infection within the sensor placement area
- Laparotomy within lower abdomen
- Participated in this study before
- In other clinical trails
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Blood-Interstitial Glucose Gap and Its Prediction of Metabolism and Prognosis in Critically Ill Patients
Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive nature, significant cost, and limited feasibility in patients on advanced life support, such as extracorporeal membrane oxygenation (ECMO). Dysregulation of glucose metabolism is common in this population, characterized not only by absolute dysglycemia but also-and perhaps more critically-by impairments in the efficiency of glucose transport and utilization across the microcirculatory continuum (from arterial blood, through the interstitial space, to venous return). This study seeks to examine the relationship between novel dynamic metrics-such as the arterio-interstitial glucose gradient-and key clinical parameters, including energy expenditure, organ function, and patient outcomes. Our objective is to assess the utility of these measures as minimally invasive, real-time biomarkers of metabolic state in critical illness.
Read the detailed description
This prospective observational study aims to investigate the association between blood-interstitial fluid glucose concentration differences and resting energy expenditure, organ function, and clinical outcomes in critically ill patients, while also exploring potential factors influencing these glucose concentration differences.
- Conditions
- Critical Illness, Metabolism Disorders
- Keywords
- Glucose Gap, Metabolic Monitoring, Prognosis, Insulin Resistance
- Medical subject headings
- Critical Illness, Metabolic Diseases, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
The incidence of all-cause death during the patient's stay in the Intensive Care Unit
Measured: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days
Secondary outcomes (3)
Duration of Vasopressor Dependency
The total length of time a patient requires continuous intravenous vasoactive drugs to maintain adequate blood pressure.
Measured: From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days
Duration of Invasive Mechanical Ventilation
The total length of time a patient requires endotracheal intubation and support from a mechanical ventilator.
Measured: From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days
Duration of Continuous Renal Replacement Therapy (CRRT)
The total length of time a patient requires continuous renal replacement therapy for acute kidney injury.
Measured: From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start13 Jul 2023
- Primary completion13 Mar 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wenkui Yu, Professor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251764
- Sponsor's protocol ID
- Zhibo Zhang
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Blood-Interstitial Glucose Gap and Its Prediction of Metabolism and Prognosis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07251764
- Acronym / sponsor ID
- Zhibo Zhang
- Conditions
- Critical Illness, Metabolism Disorders
- Keywords
- Glucose Gap, Metabolic Monitoring, Prognosis, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive nature, significant cost, and limited feasibility in patients on advanced life support, such as extracorporeal membrane oxygenation (ECMO). Dysregulation of glucose metabolism is common in this population, characterized not only by absolute dysglycemia but also-and perhaps more critically-by impairments in the efficiency of glucose transport and utilization across the microcirculatory continuum (from arterial blood, through the interstitial space, to venous return). This study seeks to examine the relationship between novel dynamic metrics-such as the arterio-interstitial glucose gradient-and key clinical parameters, including energy expenditure, organ function, and patient outcomes. Our objective is to assess the utility of these measures as minimally invasive, real-time biomarkers of metabolic state in critical illness.
Detailed description
This prospective observational study aims to investigate the association between blood-interstitial fluid glucose concentration differences and resting energy expenditure, organ function, and clinical outcomes in critically ill patients, while also exploring potential factors influencing these glucose concentration differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patient
Key inclusion criteria (4 listed)
- Age≥ 18 years and < 80 years
- ICU stay ≤48 hours
- Expected ICU stay > 24 hours
- APACHE II score≥ 8
Key exclusion criteria (4 listed)
- local infection within the sensor placement area
- Laparotomy within lower abdomen
- Participated in this study before
- In other clinical trails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU Mortality
Time frame: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days
The incidence of all-cause death during the patient's stay in the Intensive Care Unit
3 secondary outcomes
Duration of Vasopressor Dependency
Time frame: From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days
Duration of Invasive Mechanical Ventilation
Time frame: From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days
Duration of Continuous Renal Replacement Therapy (CRRT)
Time frame: From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenkui Yu, Professor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Metabolism Disorders, run by Chinese Medical Association at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 4 Nov 2026.